Dáil Éireann Debate, Tuesday - 19 June 2012
113Deputy Dara Calleary asked the Minister for Health the reasons for the delay in the provision of the drug Gilenya to patients with multiple sclerosis; if his attention has been drawn to the fact that the drug has the potential to transform the lives of many who suffer from MS; and if he will make a statement on the matter. [29440/12]
Amharc ar fhreagra609Deputy Michelle Mulherin asked the Minister for Health following the decision by the National Council for Pharma Economics on 22 September 2011 to approve the drug Fingolimod, Gilenya as a cost-effective therapy for the treatment of relapsing-remitting multiple sclerosis patients in the Irish healthcare setting, when this drug will be made available to all patients who need it; and if he will make a statement on the matter. [29211/12]
Amharc ar fhreagra615Deputy Finian McGrath asked the Minister for Health if he will provide an update on the drug Gilewya made by a company called Novortis and which is given free to multiple sclerosis patents; if it will be on the long term illness scheme and any if he will update on this drug [29275/12]
Amharc ar fhreagra654Deputy Alan Farrell asked the Minister for Health the time frame for when Gilenya will be available on the long term illness scheme; and if he will make a statement on the matter. [29630/12]
Amharc ar fhreagra672Deputy Brendan Griffin asked the Minister for Health when the drug Gilenya will become available and the reason for the delay; and if he will make a statement on the matter. [29778/12]
Amharc ar fhreagraI propose to take Questions Nos. 113, 609, 615, 654, 672 and 695 together.
The manufacturer of fingolimod, Gilenya®, has submitted an application to the Health Service Executive for the product to be reimbursed through community pharmacies under the high-tech drug scheme. The list of medicinal products provided under the scheme is reviewed on a regular basis. The application in respect of the product in question is under consideration.
The HSE has identified the potential for a significant budget impact with this product and it has, therefore, been referred to the HSE drugs group which examines how new medicines can be introduced into clinical care pathways as and when resources become available. In addition, the chief medical officer has been requested to engage with the HSE to examine the current decision making process and ensure a robust system is in place to drive decision making around medicines and evidence based prescribing. It is expected that the chief medical officer will report on this matter in the coming weeks.
I am pleased to inform Deputies that we have agreed with the pharmaceutical companies on a sum of moneys to be reimbursed to us which will allow us to open negotiations on a more comprehensive deal and release the new drugs in question.
I welcome the announcement that Gilenya will be made available to people suffering from multiple sclerosis. Clinical trials and international evidence show the drug can give quality of life to people with the condition. It is an oral-based therapy, which should decrease the cost of its provision by the HSE.
There is a broader issue at stake. The National Centre for Pharmacoeconomics assesses the impact of and the value for money provided by high-tech medicines. We have reduced dramatically the base level at which we consider a drug to be suitable in terms of improved quality of life. However, the reduction from €45,000 to €20,000 means we are playing God with more people. This cannot be allowed to continue and it will have a devastating impact on people's ability to access high quality, high-tech innovative drugs that make a difference in terms of quality of life.
As there are two other Deputies who wish to speak, I ask the Minister to be brief.
The pharmacological unit carries out a health technology assessment of a medication, but that is only part of the equation. The HSE has a group that further advises on and evaluates the matter above and beyond what the pharmacological unit has stated and the health technology assessment has shown. It is not true to say, therefore, that this alone decides whether a drug will be made available. The "Ipi" drug would never meet the health technology assessment requirements, but there were wider considerations taken into account by the group, given its impact on patients, and, therefore, it was made available.
I welcome the initial comments made by the Minister. He has said the decision will be made in a matter of weeks. Is he talking about two, three, five or six weeks?
It will be made as soon as is practicable. That is all I can say. In the case of some of these drugs, it is not as simple as making a decision today, following which it will be available immediately. There are other things that have to be done and the position is different in the case of each drug. There is a major responsibility on everybody to be involved, not just policymakers and politicians but also clinicians who prescribe these drugs and the drug companies that produce them. No matter how well the economy is doing, we have limited resources and have to prioritise in how we accommodate a new drug. Other drugs have to make room for it within the pot. This means that they have to drop in price. That is only right and proper. Clinicians need to engage, as do patient groups, as well as policymakers and politicians.
I add my voice to those who have called for this drug to be made available to multiple sclerosis sufferers. It is available in the neighbouring jurisdiction and most European countries. At last Thursday's meeting of the Oireachtas health committee the Minister rightly referred to the frustration caused in engaging with the pharmaceutical industry, particularly by its slowness to engage, bring down prices and address all of these issues. Will he elaborate on the progress he is making in making Gilenya available? Is the slowness of the industry to engage a factor in this regard? What about its reluctance to accept the critical need to reduce the high cost of medicines for all citizens?
I welcome the announcement made by the Minister. However, the pharmacoeconomics centre stated recently that €45,000 was the threshold. Who decided that it should be reduced to €20,000? This rules out a lot of high-tech drugs being made available or which it is recommended should be made available at the very least. This is a fundamental factor in the availability of high-tech and breakthrough drugs.
The decision was made within the HSE and the pharmacological unit. I will have to find out for the Deputy precisely which individuals were involved. As the drugs are being made available, nobody will suffer loss as a consequence. The last thing anybody wants to do, or the last thing anybody should do, he or she a doctor, a politician or the Minister for Health, is to play God. That is a not a place I ever want to be in. We have to have a societal answer which involves all of the people mentioned, namely, clinicians, pharmaceutical companies, politicians and members of society at large, as represented by patient groups and others. We are always going to have this issue, especially the question of how drugs are priced. Sometimes one wonders if prices are just plucked out of the air. We all understand research and development are very important and encourage those involved, as we are very mindful of the importance of the pharmaceutical industry in this country. At the same time, however, some of the prices need to be subject to scrutiny. We will be doing this. To answer Deputy Ó Caoláin's question, the drugs reference pricing Bill which will be brought forward before the summer will go a long way towards addressing this issue.
